Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma

A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis

The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.

The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.

Inclusion Criteria:

• Bronchial asthma
• Requirements for inhaled corticosteroid
• Positive skin prick test to house dust mite
• Positive radioallergosorbent test (RAST) to house dust mite
• Positive provocation test result to house dust mite

Exclusion Criteria:

• Serious chronic diseases
• Other perennial allergies